Physiotherapeutic Intervention in Children With Chronic Functional Constipation

NCT00906971 | Completed Results DMC

• 1 other identifier: posca-832
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether physiotherapy is effective in the treatment of the chronic functional constipation in children.

Conditions

Chronic Constipation

Keywords

Physical Therapy; Chronic Functional Constipation; Children

Outcome Measures

Primary Outcomes (2)

• Frequency of Defecation.

  The patients (or their parents) received a bowel diary and they fulfilled about frequency of defecation weekly.

  six weeks

• Retentive Fecal Incontinence.

  Retentive fecal incontinence is the lose of fecal while the patient tries to avoid the bowel movement. The patients (or their parents) received a bowel diary and they fulfilled about frequency of episodes of retentive fecal incontinence weekly.

  six weeks

Study Arms (1)

Laxatives

ACTIVE COMPARATOR

Magnesium hydroxide for which the dosage varied according to individual needs (a minimum of 2 ml/kg), and received guidance regarding fiber-rich foods, water and toilet training. Patients attended weekly consultations with a pediatric gastroenterologist.

Other: diaphragmatic breathing, isometric training of the abdominal muscles and abdominal massage

Interventions

diaphragmatic breathing, isometric training of the abdominal muscles and abdominal massage OTHER

Exercises will be conducted by one physiotherapist. A one-minute rest period will be observed between each series. Isometric training of the abdominal muscles: This will consist of a contraction of the upper abdomen muscle and diaphragm and the simultaneous relaxation of the lower abdomen. Training will be carried out in two manners: with the patient lying in a left lateral decubitus position with the hip and knee flexed at 90º and sitting. Breathing exercises: With the patient in a seated position, with one hand placed on the abdomen and the other on the thorax, and will be instructed to breath in slowly,. Two series will be completed, with ten repetitions. Abdominal massage: The physiotherapist will perform slow circular clockwise movements, along the line of the colon, with a regular tennis ball, remaining on each point for one minute, beginning with the ascending colon moving in the direction of the sigmoid colon.

Laxatives

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Less than 2 per week defecation
• Fecal incontinence
• Retentive behavior
• Pain at defecation and
• Hard stools

You may not qualify if:

• Medication use (calcium, antacid, diuretic and hematinic)
• Organic causes (spina bifid, hypothyroidism, hirschusprung disease, developmental delay neuropsychomotor, kidney disease and metabolic diseases)

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Hospital's Clinical - UFPE

Recife, Pernambuco, 50670-420, Brazil

Location

Limitations and Caveats

The study was not designed to assess if a longer period of physiotherapy using these exercises could bring more clinical benefits to bowel habits, therefore, further studies should be undertaken to assess longer treatment periods, of 6 to 12 months.

Results Point of Contact

• Title: Carlos André Gomes Silva
• Organization: Universidade Federal de Pernambuco

carlosandrejpa@hotmail.com

+55 83 9913-4949

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master

Study Record Dates

• First Submitted: May 19, 2009
• First Posted: May 21, 2009
• Study Start: March 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: April 1, 2010
• Last Updated: November 12, 2012
• Results First Posted: October 18, 2012

Record last verified: 2012-11

Locations

BR (1)